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NCT00253734 · ClinicalTrials.gov registry record · Phase 2

Immunogenicity and Safety of Different Doses of Fluzone® Influenza

A Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
217
Enrollment target
1
Study location

NCT00253734 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 217 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00253734, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
217 participants
Enrollment target
1
Study location

Study Summary

The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.

Conditions Studied

Interventions

  • BIOLOGICAL Fluzone®
  • BIOLOGICAL Fluzone® (IM)

Study Locations (1)

Missouri

  • Saint Louis University - St Louis

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2005-11
Est. Completion 2006-11
Phase Phase 2

What the Registry Record Tells You About NCT00253734

The ClinicalTrials.gov registry entry for NCT00253734 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Fluzone® is the first listed.

NCT00253734 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT00253734 about?

NCT00253734 is a clinical study titled "Immunogenicity and Safety of Different Doses of Fluzone® Influenza". The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be u...

What is the current status of trial NCT00253734?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2005-11. Estimated completion is 2006-11.

What conditions does trial NCT00253734 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT00253734?

The interventions under investigation include: Fluzone® (BIOLOGICAL), Fluzone® (IM) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00253734?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00253734 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.